PlainRecalls
FDA Drug Moderate Class II Terminated

guaiFENesin ER, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000815

Reported: January 22, 2014 Initiated: July 2, 2013 #D-682-2014

Product Description

guaiFENesin ER, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000815

Reason for Recall

Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: AD21965_13, EXP: 5/1/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD56917_7, EXP: 5/21/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD73627_17, EXP: 5/30/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W003216

Details

Recalling Firm
Aidapak Services, LLC
Units Affected
600 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location
Vancouver, WA

Frequently Asked Questions

What product was recalled?
guaiFENesin ER, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000815. Recalled by Aidapak Services, LLC. Units affected: 600 Tablets.
Why was this product recalled?
Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: AD21965_13, EXP: 5/1/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD56917_7, EXP: 5/21/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD73627_17, EXP: 5/30/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W003216
Which agency issued this recall?
This recall was issued by the FDA Drug on January 22, 2014. Severity: Moderate. Recall number: D-682-2014.